Last updated: 07/10/2020 18:50:05
A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the beta-3-Adrenergic Receptor Agonist Solabegron in Subjects with Irritable Bowel Syndrome
Trial description: This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
completion of questionnaires by the subject, determining the average adequate relief rate
Timeframe: during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)
Secondary outcomes:
Blood levels of GW427353
Timeframe: Week 1, 13
Questionnaire
Timeframe: Weeks 1, 6, 12, 18, 24
ECG, vital signs, adverse events
Timeframe: each visit
clinical lab tests
Timeframe: Weeks 1, 6, 12, 18, 24
Interventions:
Drug: GW427353
Drug: Placebo
Enrollment:
100
Observational study model:
Not applicable
Primary completion date:
2007-14-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Irritable Bowel Syndrome (IBS)
Product
solabegron
Collaborators
Not applicable
Study date(s)
August 2006 to June 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
no
- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain)
- Subjects not meeting the Rome II criteria for the diagnosis of IBS
- Subjects with no stool for 7 days during the screen
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain)
Exclusion criteria:
- Subjects not meeting the Rome II criteria for the diagnosis of IBS
- Subjects with no stool for 7 days during the screen
Trial location(s)
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
Status
Study Complete
Location
GSK Investigational Site
Concord, New South Wales, Australia, 2139
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Spring Hill, Queensland, Australia, 4000
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2007-14-06
Actual study completion date
2007-14-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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